Clinical Research Directory

A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration

The aim of this trial is to demonstrate similarity in efficacy between ABP 938 8 mg and aflibercept (US) 8 mg by evaluating the change in best corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (nAMD)

A Study to Compare GNR-139 and Eylea® in Patients With nAMD

This is a multicenter, randomized, double-blind study designed to compare the efficacy and safety of the investigational drug GNR-139 with the reference drug Eylea in treatment-naive patients with neovascular age-related macular degeneration (nAMD). Participants will be randomly assigned to receive either GNR-139 or Eylea. Neither the participants nor the study doctors will know which treatment is being administered. Both drugs will be given as an intravitreal injection dose of 8 mg (0.07 mL at a concentration of 114.3 mg/mL). Patients meeting the eligibility criteria will be randomised in a 2:1 ratio into one of two treatment groups: * Group I (GNR-139): 120 patients; * Group II (Eylea®): 60 patients. The main goal of the study is to evaluate if GNR-139 has similar efficacy to Eylea. This will be determined by measuring the change in the Best-Corrected Visual Acuity (BCVA) score at Week 8 in participants who completed the treatment.

A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)

This study will evaluate the efficacy, safety, and PK of ranibizumab 100 milligrams per milliliter (mg/mL) delivered every 24 weeks (Q24W) via the PDS implant compared with ranibizumab 0.5 milligrams (mg) delivered every 4 weeks (Q4W) as intravitreal (IVT) injection in Chinese participants with nAMD.

Real-World Study of Intravitreal Aflibercept 8 mg in Pretreated Eyes With nAMD or DME

The goal of this multicentre observational study is to evaluate the interval-extension potential, effectiveness, and safety of intravitreal aflibercept 8 mg in pretreated eyes with neovascular age-related macular degeneration (nAMD) or diabetic macular oedema (DME) under routine clinical practice in Portugal. It consists in an ambidirectional longitudinal cohort with retrospective collection of pre-switch clinical and treatment history and prospective follow-up after initiation of intravitreal aflibercept 8 mg in routine clinical practice. The main questions it aims to answer are: \- Can treatment intervals be extended after switching to intravitreal aflibercept 8 mg while maintaining disease control in pretreated eyes with nAMD or DME? What are the functional, anatomical, and safety outcomes associated with intravitreal aflibercept 8 mg in routine clinical practice? Participants are adults with nAMD or DME who have previously received intravitreal treatment and are switched to aflibercept 8 mg as part of routine clinical care. No study-specific interventions or procedures are performed. Clinical data are collected prospectively through the Portuguese national Retina.PT registry during routine follow-up visits, including treatment patterns, injection intervals, visual acuity, retinal anatomical assessments, and ocular and systemic safety outcomes.

Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD

ABBV-RGX-314 (also known as RGX-314 and surabgene lomparvovec (sura-vec)) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.

Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD

ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD or nAMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (anti-VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to maintain or prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every 4 to 16 weeks in frequency, to maintain efficacy. Due to the burden of these treatments, patients often experience a decline in vision with reduced frequency of treatment over time.

Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, PK and Efficacy of SCT520FF in Patients With nAMD

Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.

Safety and Efficacy Study of IVB103 Injection in Subjects With Neovascular (Wet) Agerelated Macular Degeneration (nAMD).

The goal of this clinical trial is to evaluate the safety and efficacy of IVB103 injection in subjects with nAMD.